Practical software testing for an FDA-regulated environment
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Unlike hardware, software does not degrade over time or frequency use. This is good for software. Also unlike hardware, software can be easily changed. This unique characteristic gives software much of its power, but is also responsible for possible failures in software applications. When software is used within medical devices, software failures may result in bodily injury or death. As a result, regulations have been imposed on the makers of medical devices to ensure their safety, which includes the safety of the devices’ software. The U.S. Food and Drug Administration requires establishment of systems and control processes to ensure quality devices. A principal part of the quality assurance effort is testing. This paper explores the unique role of software testing in the design, development, and release of software used for medical devices and applications. It also provides practical, industry-driven guidance on medical device software testing techniques and strategies.